BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

    MDR report key: 1101952 · Received August 6, 2008

    Report

    Report Number
    2024601-2008-00408
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 7, 2008
    Manufacturer
    BIOENTERICS CORPORATION
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON: 06/AUG/08. THE PRODUCT ASSOCIATED WITH THIS REPORT WILL NOT BE RETURNED AS THE DEVICE WAS DISCARDED BY THE SURGEON AFTER EXPLANTING THE DEVICE. THE REPORTER OF THE COMPLAINT WAS ASKED TO INDICATE THE PRODUCT SERIAL NUMBER, DATE OF EVENT, AND THE EXPLANT DATE. THE INFORMATION HAS NOT YET BEEN RECEIVED BY ALLERGEN. BASED UPON THE IMPLANT DATE PROVIDED BY THE REPORTER THE CONNECTOR TYPE IS ASSUMED TO BE A TAPER I. ALLERGEN HAS NOT RECEIVED THE PRODUCT. THEREFORE, NO ANALYSIS OR TESTING HAS BEEN DONE. FURTHER INFORMATION FROM THE REPORTER REGARDING THE SERIAL NUMBER, THE EXPLANT DATE, AND THE DATE OF THE EVENT HAS BEEN REQUESTED. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    REPORTED AS "DEFECT ON THE PORT." (LEAK)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM DEVICE FOR TREATMENT OF MORBID OBESITY LTI BIOENTERICS CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR